510(k) Report

FDA applicant

Prognosys Medical Systems Private Limited

Bangalore, IN3 decisions2019–20250 recalls

FDA records 3 decisions for Prognosys Medical Systems Private Limited (Bangalore, IN) from 2019 to 2025: 3 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and KPR (System, X-Ray, Stationary). Since 2016 its 510(k)s took a median of 236 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Prognosys Medical Systems Private Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2019: 12024: 12025: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Prognosys Medical Systems Private Limited by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)1decision
  • KPRSystem, X-Ray, Stationary1decision
  • IZLSystem, X-Ray, Mobile1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 236 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 153 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K243473Prorad Atlas Ultraportable; Prorad Atlas Ultraportable PlusPrognosys Medical Systems Private Limited · 2025
  • K240771PRORAD X-Ray Flat Panel Detector with DROCPrognosys Medical Systems Private Limited · 2024
  • K183541ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited · 2019

All 3 as Prognosys Medical Systems Private Limited →